Trial Outcomes & Findings for Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain (NCT NCT04636177)
NCT ID: NCT04636177
Last Updated: 2025-11-14
Results Overview
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline to end of treatment across 6-8 weeks, on average
Results posted on
2025-11-14
Participant Flow
This was originally conceived as a two-arm study, with patients randomized 1:1 to Pain Rehabilitation Virtual Reality (PRVR) or Standard Physiotherapy Rehabilitation (SPR). Early in the study, the design was changed from that point all participants were allocated to the PRVR arm.
Participant milestones
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Two-arm, randomization portion
STARTED
|
4
|
6
|
|
Two-arm, randomization portion
COMPLETED
|
3
|
4
|
|
Two-arm, randomization portion
NOT COMPLETED
|
1
|
2
|
|
Single-arm portion
STARTED
|
24
|
0
|
|
Single-arm portion
COMPLETED
|
22
|
0
|
|
Single-arm portion
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Two-arm, randomization portion
Withdrawal by Subject
|
1
|
1
|
|
Two-arm, randomization portion
Lost to Follow-up
|
0
|
1
|
|
Single-arm portion
Withdrawal by Subject
|
1
|
0
|
|
Single-arm portion
Adverse Event
|
1
|
0
|
Baseline Characteristics
Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
Baseline characteristics by cohort
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=28 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=6 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
34 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Female
|
12 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Male
|
14 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
34 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of treatment across 6-8 weeks, on averagePopulation: Participants who completed the protocol
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Outcome measures
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=25 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=4 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
VR Duration of Use Per Week
|
30.5 Minutes per week
Standard Deviation 39.52
|
17.0 Minutes per week
Standard Deviation 6.36
|
PRIMARY outcome
Timeframe: End of treatment at 6-8 weeks, on averagePopulation: Participants who completed the protocol
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Outcome measures
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=25 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=4 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Participant Rated Ease of Use
Very easy
|
13 Participants
|
0 Participants
|
|
Participant Rated Ease of Use
Easy
|
6 Participants
|
3 Participants
|
|
Participant Rated Ease of Use
A little easy
|
4 Participants
|
0 Participants
|
|
Participant Rated Ease of Use
Not at all easy
|
0 Participants
|
0 Participants
|
|
Participant Rated Ease of Use
No Response
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: End of treatment at 6-8 weeks, on averagePopulation: Participants who completed the protocol
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Outcome measures
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=25 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=4 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Participant Rated Enjoyment
Enjoyed very much
|
5 Participants
|
0 Participants
|
|
Participant Rated Enjoyment
Enjoyed
|
10 Participants
|
0 Participants
|
|
Participant Rated Enjoyment
Enjoyed a little
|
5 Participants
|
3 Participants
|
|
Participant Rated Enjoyment
Not at all
|
0 Participants
|
0 Participants
|
|
Participant Rated Enjoyment
No response
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatmentPopulation: Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.
Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. Total score range: Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes.
Outcome measures
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=28 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=6 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Pain-related Fear and Avoidance
baseline
|
21.00 score on a scale
Standard Deviation 8.67
|
18.00 score on a scale
Standard Deviation 3.41
|
|
Pain-related Fear and Avoidance
end of treatment
|
15.84 score on a scale
Standard Deviation 9.66
|
17.5 score on a scale
Standard Deviation 11.7
|
|
Pain-related Fear and Avoidance
3-month follow-up
|
15.58 score on a scale
Standard Deviation 8.05
|
22.00 score on a scale
Standard Deviation 13.64
|
SECONDARY outcome
Timeframe: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatmentPopulation: Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.
Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. Overall score range: Min=0, Max=80; lower score indicates greater disability/worse outcomes.
Outcome measures
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=28 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=6 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Physical Function: Lower Extremity
baseline
|
54.64 score on a scale
Standard Deviation 14.13
|
46.83 score on a scale
Standard Deviation 19.90
|
|
Physical Function: Lower Extremity
end of treatment
|
63.24 score on a scale
Standard Deviation 11.57
|
57.75 score on a scale
Standard Deviation 16.64
|
|
Physical Function: Lower Extremity
3-month follow-up
|
66.76 score on a scale
Standard Deviation 11.73
|
71.50 score on a scale
Standard Deviation 9.57
|
SECONDARY outcome
Timeframe: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatmentPopulation: Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.
Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of upper extremity functioning. Overall score range: 0 to 80, with greater scores indicating increased upper extremity functioning.
Outcome measures
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=28 Participants
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=6 Participants
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Physical Function: Upper Extremity
baseline
|
64.07 score on a scale
Standard Deviation 12.84
|
69.83 score on a scale
Standard Deviation 14.61
|
|
Physical Function: Upper Extremity
end of treatment
|
67.48 score on a scale
Standard Deviation 10.42
|
75.75 score on a scale
Standard Deviation 3.5
|
|
Physical Function: Upper Extremity
3-month follow-up
|
72.40 score on a scale
Standard Deviation 7.96
|
78.00 score on a scale
Standard Deviation 3.37
|
Adverse Events
Pain Rehabilitation Virtual Reality (PRVR)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard Physiotherapy Rehabilitation (SPR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pain Rehabilitation Virtual Reality (PRVR)
n=28 participants at risk
PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks).
|
Standard Physiotherapy Rehabilitation (SPR)
n=6 participants at risk
SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks).
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Up to 6 months
|
0.00%
0/6 • Up to 6 months
|
Additional Information
Laura E Simons
Stanford University School of Medicine
Phone: (650) 736-0838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place